News : Ethics ignored in clinical trials

June 18: Although as many as 500 clinical trials take place in India, the WHO points out that there are less than 40 ethics committees which are properly constituted and monitor the trials. A large number of pharma companies, medical colleges and reputed hospitals, including those under the government's control, flout rules on the ethics panel. Every clinical trial needs to be cleared by the locally-constituted ethics committee before it is approved by the Central Drugs Standards Control Organisation. The trial should be registered with the Clinical Trials Registry of India, managed by the Indian Council of Medical Research. Clinical trials are not illegal, but most of the organisations, including reputed hospitals, take advantage of the poverty in rural areas and recruit economically disadvantaged people. Objecting strongly to the practice of recruiting volunteers for clinical trials from among the poor, the WHO has noted that fewer than 40 ethics committees in India are properly constituted and functioning. This means, more than 90 per cent of clinical trials conducted in the country are “unethical”, though not illegal. There is no legal requirement for investigators or members of the ethics committees to declare a conflict of interest. “There’s the need for ensuring that guidelines for constitution and functioning of ethics committee are implemented. Review of the documents submitted to Clinical Trials Registry reveals the extent of improper functioning of several ethics committees,” regrets Dr Arvind Pandey of CTRI. In many cases the trial’s contact person for scientific and public query, is also the member secretary of the ethics committee and signing authority of the EC approval.